MAUDE Adverse Event Report: HOLOGIC, INC MULTICARE PLATINUM; STEREOTACTIC BREAST BIOPSY SYSTEM

Model Number 8-004-0017

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

Event Type  malfunction  

Event Description

It was reported that the carm is intermittently not staying locked during exposure.No injury reported.A field engineer was dispatched to the site and determined that the membrane switch needed to be replaced.Once this was completed the system was working as intended.

• Brand Name: MULTICARE PLATINUM
• Type of Device: STEREOTACTIC BREAST BIOPSY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 9011592
• MDR Text Key: 178784684
• Report Number: 1220984-2019-00099
• Device Sequence Number: 1
• Product Code: IZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8-004-0017
• Device Catalogue Number: 8-004-0017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1